Associate Director, Quality GCP

Verastem Oncology

. Develop and implement Quality Programs where needed .

Posted 11/6/2026full-timeBoston • Massachusetts • United StatesSenior💰 $170,000 - $200,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in developing and implementing GCP Quality Programs and risk-based strategies, with a strong focus on compliance, quality assurance, and audit management in clinical research. Proven ability to lead cross-functional teams and manage stakeholder relationships effectively.

Highest-signal resume keywords

GCP Quality Assurance ExperienceClinical Research and DevelopmentInspection Readiness ProgramsAudit Planning and ReportingGCP EU, FDA, and ICH Regulations

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality Program DevelopmentRisk-Based GCP StrategiesGCP Quality StandardsClinical Vendor Risk AssessmentsAudit ManagementRoot Cause AnalysisCorrective Action PlansClinical Quality Metrics DevelopmentQuality and Compliance TrainingGCP Guidance

Soft Skills

Excellent Collaboration SkillsStrong Interpersonal SkillsOrganizational SkillsVerbal and Written Communication SkillsAbility to Multitask

Tools & Technologies

Veeva Systems

Industry Keywords

Drug DevelopmentBiologicsPharmaceutical IndustryGLP Quality AssuranceGVP Quality Assurance

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Develop and implement Quality Programs where needed
Develop and implement risk-based GCP strategies across clinical programs and/or studies
Manage and/or support development, enhancement, review, and implementation of GCP quality standards and controlled documents, including SOPs, Work Instructions, and Templates
Promote compliance and quality throughout the company and represent the Quality Department in internal meetings and events
Build, develop, and maintain working relationships with internal and external partners
Provide input and expertise to clinical vendor risk assessments
Plan, conduct, and manage audits of clinical trial sites, vendors, and/or internal processes, including follow-up activities such as reports and corrective actions
Coordinate internal stakeholders and external auditors to ensure audits fulfill business needs
Partner with clinical stakeholders to manage clinical vendor/site oversight and issue management
Conduct or facilitate investigations of GCP Quality Events, root cause analysis, and corrective and preventative action plans
Support Inspection Readiness activities for internal teams, clinical sites, and significant clinical service providers
Partner with stakeholders and subject matter experts to implement and manage the Clinical Risk Management Program
Lead or contribute to Clinical Quality Metrics development and maintenance for process improvement and leadership presentations
Lead development and delivery of quality and compliance training to internal functions
Provide GCP guidance to internal stakeholders and Study Management Teams
Participate in quality and cross-functional process improvement initiatives
Perform other duties assigned by Quality Assurance Management

Requirements

What you’ll need

Bachelor’s degree in related Life Sciences discipline is required; advanced degree preferred
7+ years in drug/biologics development in the biotechnology or pharmaceutical industry
4 years previous GCP Quality Assurance experience in Clinical Research and Development
Experience leading, developing and/or implementing Inspection Readiness Programs and associated activities
In-depth knowledge of and ability to interpret and apply GCP EU, FDA and ICH regulations and guidelines
Strong working knowledge/experience in planning, conducting and reporting clinical site and service provider audits
Additional related experience in GLP and/or GVP Quality Assurance is preferred
Experience with Veeva systems is a plus
Ability to identify quality issues/discrepancies and effectively and proactively manage and resolve them in a diplomatic, flexible and constructive manner
Well organized with the ability to multitask, prioritize and manage shifting responsibilities in a dynamic, cross-functional teamwork environment
Excellent collaboration skills with strong attention to detail and the ability to multitask and manage complexity
Strong interpersonal and organizational skills and excellent verbal and written communication skills are required
Ability to travel 30–50% domestically and internationally